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Parent Training Program for Preschool Children With Autism Spectrum Disorders

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
parent-training program
traditional program
Sponsored by
National Cheng Kung University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

36 Months - 71 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. children with a diagnosis of ASD according to the Diagnostic and Statistics Manual of Mental Disorders - Fifth edition (DSM-5; APA, 2013) by registered pediatric psychiatrists;
  2. mild to severe symptoms of ASD according to the Standard Version of Childhood Autism Rating Scale - Second edition (CARS2-ST; Schopler et al., 2010);
  3. children aged 36 to 71 months old;
  4. children whose primary caregivers (parents who cared for their child for over 15 hours per week - except during sleep time) used Mandarin as their main language;
  5. children whose caregivers' educational level were at or above middle school so that they could read manuals and complete the questionnaires.

Exclusion Criteria:

  1. children who attended other intensive interventions (e.g., 25 hours per week) or had been diagnosed with additional diseases or disorders;
  2. parents who attended other parent-training programs at the same time.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    parent-training program

    traditional program

    Arm Description

    Parents in the treatment group received the parent-training program based on the DIR model. The parent-training program encouraged child-initiated activities according to the functional developmental levels. The treatment intensity and duration were the same for both groups including 3-week courses and 11-week home programs. The investigators in this study are two registered pediatric occupational therapists who have at least five years of early intervention experience and had studied the DIR model.

    Parents in the control group received the traditional program based on the developmental approach. The traditional program provided parent-lead activities that fit child's developmental stage.

    Outcomes

    Primary Outcome Measures

    Change Scores of Functional Emotional Assessment Scale
    The Functional Emotional Assessment Scale (FEAS; Greenspan et al., 2001) is based on six functional developmental levels of the developmental individual-difference relationship-based model and divided into two parts that (1) examine the children's development and (2) assess the parenting skills. All parents in the study were asked to record their parent-child activities as 15-minute videos. All videos were coded using random numbers to hide the research information (e.g. groups and test time). Two videos (pre- and post-test) were reviewed for each child. Using the Chinese version of the Scoring Form translated by Liao et al. (2014; intraclass correlation coefficient = 0.85), each item of the FEAS was rated as 0, 1 or 2. Higher raw scores represent better functions and skills. The total score is summed and ranges from 0 to 80.

    Secondary Outcome Measures

    Change Scores of Chinese Version of Psychoeducational Profile - Third Edition
    The performance scale of the Chinese Version of Psychoeducational Profile-3 (Schopler et al., 2005; Heep Hong Society, 2013) comprises six subtests for developmental abilities (cognitive verbal/preverbal, expressive language, receptive language, fine motor, gross motor and visual-motor imitation), which are summed to create communication and motor composites. The score of each item is rated as 0, 1 or 2. All six subtests for developmental abilities can be converted to age-equivalent and composite scores. The communication and motor composites scores range from 0 to 60. The higher the scores are, the better function the children achieve.
    Change Scores of Vineland Adaptive Behavior Scales
    The Vineland Adaptive Behavior Scales (VABS; Sparrow et al., 1984) comprises four domains, that is, communication, daily living skills, socialization and motor skills, for assessing adaptive functioning in children aged 3 to 12 years old. The raw score in each domain and total raw score are converted to an age-equivalent score. The domain scores are also expressed as standard scores with a mean of 100 and standard deviation of 15. The range for each subscale is from 20 to 140. The subscales are summed to compute a total score, ranging from 80 to 560. The higher the scores are, the better adaptive functioning the children achieve.

    Full Information

    First Posted
    October 26, 2018
    Last Updated
    October 29, 2018
    Sponsor
    National Cheng Kung University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03725644
    Brief Title
    Parent Training Program for Preschool Children With Autism Spectrum Disorders
    Official Title
    Effectiveness of Floortime Intervention Program for Preschool Children With Autism Spectrum Disorders
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 29, 2015 (Actual)
    Primary Completion Date
    September 30, 2017 (Actual)
    Study Completion Date
    September 30, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Cheng Kung University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Previous research has showed that parent-training programs derived from the developmental individual-difference relationship-based model (DIR) could improve the communicative development of children with autism spectrum disorder (ASD). However, the empirical evidence is weak. This study therefore examines whether a DIR-based parent-training program can improve children's adaptive functioning and parents' parenting skills using a rigorous randomized controlled trial design with a dose-matched control group. Forty preschool children with autism spectrum disorder (ASD) and their parents were randomly assigned to the parent-training program group or the traditional program group at the pre-test phase. Both groups received 14-week intervention programs and were assessed using pre- and post-tests. Children's development levels and adaptive functioning were assessed by the Functional Emotional Assessment Scale (FEAS), the Chinese version of Psychoeducational Profile-third edition (CPEP-3), and the Vineland Adaptive Behavior Scales (VABS). In addition, parents' parenting skills were assessed by the FEAS and parenting stress was evaluated by the Parenting Stress Index-Short Form.
    Detailed Description
    Introduction: Preschool children with autism spectrum disorder and their parents face many difficulties in daily lives, including children's adaptive functioning, parenting skills, and parenting stress. Therefore, effective and economical interventions are very important to support them. With appropriate theoretical bases, a parent-training program could be effective, economical, and feasible while the clinical manpower is insufficient. Among current intervention programs, the play concept and the developmental, individual difference, and relationship-based (DIR) model match the philosophy of occupational therapy. Previous research had showed the play- and DIR-based parent-training programs would improve children's communicative development. However, the empirical evidence was still weak due to poor research designs and little research was comprehensively investigated children's adaptive functioning. Moreover, the results of improvement in parenting skills and reduction of parenting stress were not consistent. Aim: This study would implement a dose-matched control group and comprehensive measurements to examine if the play- and DIR-based parent-training program would improve children's adaptive functioning and parents' parenting skills as well as reduce parenting stress. Hypotheses: We hypothesized that the better improvements would show in the parent-training program than those in the traditional program. Method: We recruited 40 preschool children with autism spectrum disorder and their parents and randomly assigned them to either the parent-training program group or the traditional program group after pretest phase. Both of them conducted 14-week intervention programs and were assessed after interventions. Children's development levels and adaptive functioning were assessed by the Functional Emotional Assessment Scale (FEAS), the Chinese version of Psychoeducational Profile-third edition (CPEP-3), and the Vineland Adaptive Behavior Scales (VABS). In addition, parents' parenting skills were assessed by the FEAS and parenting stress was evaluated by the Parenting Stress Index-Short Form.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Autism Spectrum Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    parent-training program
    Arm Type
    Experimental
    Arm Description
    Parents in the treatment group received the parent-training program based on the DIR model. The parent-training program encouraged child-initiated activities according to the functional developmental levels. The treatment intensity and duration were the same for both groups including 3-week courses and 11-week home programs. The investigators in this study are two registered pediatric occupational therapists who have at least five years of early intervention experience and had studied the DIR model.
    Arm Title
    traditional program
    Arm Type
    Experimental
    Arm Description
    Parents in the control group received the traditional program based on the developmental approach. The traditional program provided parent-lead activities that fit child's developmental stage.
    Intervention Type
    Behavioral
    Intervention Name(s)
    parent-training program
    Intervention Description
    Parents in the treatment group received the training program from the registered pediatric occupational therapist in six hours over three weeks. The occupational therapist provided suggestions and gave feedback. The parents were encouraged to interact with their children for at least 15 hours per week. Between the fourth and 14th weeks, the parents implemented the intervention programs at home and recorded the daily intensity. The occupational therapist met with the parents and children at monthly intervals (the seventh and 11th weeks) at the laboratory to discuss any difficulties they encountered and to practice the child-initiated activities.
    Intervention Type
    Behavioral
    Intervention Name(s)
    traditional program
    Intervention Description
    Parents in the control group also conducted a 14-week program. They received six hours of training over three weeks.Between the fourth and 14th weeks, the parents implemented parent-led activities at home and recorded the daily intensity. The parents were encouraged to do activities with their children for at least 15 hours per week. The occupational therapist met with the parents at monthly intervals (the seventh and 11th weeks) at the laboratory to discuss any difficulties they encountered while practicing the parent-led activities.
    Primary Outcome Measure Information:
    Title
    Change Scores of Functional Emotional Assessment Scale
    Description
    The Functional Emotional Assessment Scale (FEAS; Greenspan et al., 2001) is based on six functional developmental levels of the developmental individual-difference relationship-based model and divided into two parts that (1) examine the children's development and (2) assess the parenting skills. All parents in the study were asked to record their parent-child activities as 15-minute videos. All videos were coded using random numbers to hide the research information (e.g. groups and test time). Two videos (pre- and post-test) were reviewed for each child. Using the Chinese version of the Scoring Form translated by Liao et al. (2014; intraclass correlation coefficient = 0.85), each item of the FEAS was rated as 0, 1 or 2. Higher raw scores represent better functions and skills. The total score is summed and ranges from 0 to 80.
    Time Frame
    14 weeks
    Secondary Outcome Measure Information:
    Title
    Change Scores of Chinese Version of Psychoeducational Profile - Third Edition
    Description
    The performance scale of the Chinese Version of Psychoeducational Profile-3 (Schopler et al., 2005; Heep Hong Society, 2013) comprises six subtests for developmental abilities (cognitive verbal/preverbal, expressive language, receptive language, fine motor, gross motor and visual-motor imitation), which are summed to create communication and motor composites. The score of each item is rated as 0, 1 or 2. All six subtests for developmental abilities can be converted to age-equivalent and composite scores. The communication and motor composites scores range from 0 to 60. The higher the scores are, the better function the children achieve.
    Time Frame
    14 weeks
    Title
    Change Scores of Vineland Adaptive Behavior Scales
    Description
    The Vineland Adaptive Behavior Scales (VABS; Sparrow et al., 1984) comprises four domains, that is, communication, daily living skills, socialization and motor skills, for assessing adaptive functioning in children aged 3 to 12 years old. The raw score in each domain and total raw score are converted to an age-equivalent score. The domain scores are also expressed as standard scores with a mean of 100 and standard deviation of 15. The range for each subscale is from 20 to 140. The subscales are summed to compute a total score, ranging from 80 to 560. The higher the scores are, the better adaptive functioning the children achieve.
    Time Frame
    14 weeks
    Other Pre-specified Outcome Measures:
    Title
    Intensity daily logs
    Description
    All parents recorded intensity (intervention hours per day) using the online Google form or paper daily logs so that their compliance with program implementation could be monitored. The parents also recorded the intensity of the regular interventions that the children received.
    Time Frame
    14 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    36 Months
    Maximum Age & Unit of Time
    71 Months
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: children with a diagnosis of ASD according to the Diagnostic and Statistics Manual of Mental Disorders - Fifth edition (DSM-5; APA, 2013) by registered pediatric psychiatrists; mild to severe symptoms of ASD according to the Standard Version of Childhood Autism Rating Scale - Second edition (CARS2-ST; Schopler et al., 2010); children aged 36 to 71 months old; children whose primary caregivers (parents who cared for their child for over 15 hours per week - except during sleep time) used Mandarin as their main language; children whose caregivers' educational level were at or above middle school so that they could read manuals and complete the questionnaires. Exclusion Criteria: children who attended other intensive interventions (e.g., 25 hours per week) or had been diagnosed with additional diseases or disorders; parents who attended other parent-training programs at the same time.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ling Yi Lin
    Organizational Affiliation
    National Cheng Kung University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    All IPD that underlie results in a publication.
    IPD Sharing Time Frame
    starting in January 2023
    IPD Sharing Access Criteria
    Supporting information will be shared to pediatric occupational therapists, researchers, and parents with autism.
    IPD Sharing URL
    https://hdl.handle.net/11296/y642ft
    Citations:
    PubMed Identifier
    24865120
    Citation
    Liao ST, Hwang YS, Chen YJ, Lee P, Chen SJ, Lin LY. Home-based DIR/Floortime intervention program for preschool children with autism spectrum disorders: preliminary findings. Phys Occup Ther Pediatr. 2014 Nov;34(4):356-67. doi: 10.3109/01942638.2014.918074. Epub 2014 May 27.
    Results Reference
    result

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